Careers

Careers

Mission

At Flowonix, our patient centric approach drives the design, development, and deployment of targeted drug delivery platforms whose sole purpose is to provide physicians an optimal solution for the treatment of their patients' numerous neurological disorders.

Core Values

  • Character – The common thread of our culture. One is never wrong doing what is right.
  • Integrity – Saying exactly what we mean and doing what we say.
  • Relentless – While never at the expense of progress, we push for perfection.
  • Purpose – Optimizing patient outcomes is our greater cause.

 

It's the desire to help people with life-changing technology that drives every member of the Flowonix team. At Flowonix we believe our employees are an essential component to our long-term success, and it is this mindset that drives our commitment to offer unique career opportunities.

We are passionate about having a diverse and talented workforce to solve the big problems we are seeking to tackle. We offer a competitive health and benefits package.

Browse our current job openings below. If you do not see any current openings but are interested in joining our team, please feel free to send an email to jobs@flowonix.com 

Document Control & Regulatory Operations Specialist

Position Title: Document Control & Regulatory Operations Specialist

Reports to: Vice President, Quality Systems

Department: Quality, Regulatory & Clinical Affairs

Location: Mt. Olive, NJ

 


 

Accountability Objective: 

Coordinate the document control program and perform document services. Coordinate and administer Quality Management System training, and Corporate Compliance training for Flowonix personnel. Establish and maintain Regulatory Operations systems for efficient global regulatory filings both in electronic and hard-copy formats. 

Essential Functions:

  • Coordinate the document control program and perform document services. Assure compliance to QMS document control procedures and regulatory requirements. Monitor and improve documented systems.
  • Develop, implement and maintain program to ensure training of personnel on quality systems documentation is accomplished in a timely manner.
  • Establish and maintain Regulatory Operations system for efficient global regulatory filings and associated correspondence both in electronic and hard copy formats (EU Design Dossier, FDA submissions and all other regulatory Competent Authority correspondence).
  • Coordinate routing, approval and disposition of promotional marketing materials and reimbursement material in accordance with company procedures.
  • Assist to develop, implement and maintain a Corporate Compliance training program to ensure adequate training of personnel on Corporate Compliance Policies and procedures (including PowerPoint presentations, webinars, quizzes, etc.).
  • Maintain the Approved Supplier List and supplier documentation files.
  • Participate in regulatory inspection activities with regulatory agencies.
  • Assist with follow-up on compliance related activities.
  • Other duties as assigned, according to the changing needs of the business including but not limited to light manufacturing operations and regulatory affairs assistance.

Decision Making Authority:

Provide guidance for internal staff regarding matters of compliance with domestic and international quality standards and regulations.

Position Specifications:

1. Knowledge/Educational Requirements:

    • High School Diploma or above, Computer Skills

Preferable:

    • Knowledge of FDA Requirements, and ISO 13485:2003 standards.

2. Skills and Abilities:

Proficient with computer spreadsheets, graphics, PowerPoint and database software.  Must have verbal and written communication skills, and be effective and comfortable working individually or in a team environment.

 

3. Physical Demands/Work Environment:

Normal office environment, heavy PC usage.

 

Positions Supervised:

Direct Reports - None

Indirect Reports - None

Working Relationships:

Internal Contacts - All departments

External Contacts - Interface with consultants, agents and customers. Provide and solicit information relating to all aspects of medical device regulatory compliance. 

 

Please Click below to submit your resume to this position opening:

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Sr. Regulatory Affairs Specialist

Position Title: Sr. Regulatory Affairs Specialist

Reports to: Director of Regulatory Affairs

Department: Regulatory Affairs

Location: Mt. Olive or Mansfield, MA

 


 

Accountability Objective: 

Responsible for the completion of assigned US and OUS Regulatory Submissions for new and existing products marketed by Flowonix Medical; assure compliance with US and OUS International regulatory requirements for Class III (US) and Active Implantable Medical Devices (EU).

Essential Functions:

  • Responsible for managing the compliance with reporting requirements related to US and OUS approvals such as MDRs, Vigilance Reporting, Post Approval Study Reports, Progress Reports and reports related to IDE and PMA approvals.
  • Responsible for the preparation of OUS regulatory submissions in order to maintain the design dossier and compliance to the essential requirements for CE marking.
  • Responsible for supporting ongoing manufacturing related to regulatory affairs, such as reviewing nonconforming material reports, engineering change notices, verification and validation protocols and reports, corrective and preventative actions and compliance with regulatory approvals and internal procedures.
  • Support regulatory involvement in the overall compliance program to meet the medical device requirements of FDA and international agencies pertaining to marketing, manufacturing, quality, and product surveillance.
  • Participate in cross functional product development teams on behalf of Regulatory Affairs and Flowonix Medical. Identify and help resolve product development issues which relate to regulatory submission activities. Coach technical activities to achieve compliance with essential requirements (e.g., design control, design validation).
  • Participate in overall document management strategies which support the device history file required by FDA regulations and product design dossier required by OUS for obtaining a design examination certificate. 
  • Support ongoing activities within other departments, carry out departmental administrative duties and other duties as assigned.

Decision Making Authority:

  • Provide guidance for internal staff on regulatory and engineering matters.
  • Assigned tasks related to US and OUS regulatory submissions to support product approvals.

Position Specifications:

  • Knowledge/Educational Requirements- Minimum of Bachelors level degree with 4 years in medical device regulatory affairs; experience with U.S. and/or E.U. submissions is required. Experience with Class III medical device submissions and/or E.U. MDD/AIMD is desirable. Experience with MDR/Vigilance reporting is desirable; excellent working knowledge of US (QSR) and OUS Quality System requirements (ISO-13485) and requirements to obtain and maintain medical device marketing approvals is required.
  • Communication/Language Skills - Must be able to effectively and persuasively communicate in English language, both verbally and in writing; must be able to read and understand scientific literature and clinical articles. Prior publication experience desirable.
  • Computer/Software Literacy - Proficient with Microsoft Office Suite of software applications, especially Word, Excel, Powerpoint and Outlook; electronic submissions require expert knowledge of Adobe Acrobat 8.0 or later. Working knowledge of Microsoft Visio, Adobe Photoshop, and other document creation tools (e.g., scanning) desirable. Must be able to conduct effective research using web-based search tools and databases.
  • Technical/Problem Solving Skills - Organized with excellent technical, analytical and problem-solving abilities; strong interpersonal skills, project management and team participation skills required.
  • Physical Demands/Work Environment - Office environment, heavy PC usage; travel required up to 25% (domestic and international).

Positions Supervised:

Direct Reports - None

Indirect Reports - Administrative Staff

Working Relationships:

Internal Contacts - Heavy cross-functional contact with all departments

External Contacts - Consultants and suppliers.

 

Please Click below to submit your resume to this position opening:

APPLY HERE